RecallHawk
Class I Recall

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactur

Global Sanitizers LLC

Summary

The FDA issued a Class I for MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v by Global Sanitizers LLC. Reason: Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the lab.

Details

Source

Drug Recall

External ID

D-0780-2021

Action Date

2021-09-08

Status

Ongoing

Category

drug

Product Description

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,

Lot/Code Info: Lot No: E082020, "Best Buy": 5/21/2022

Quantity Affected: 50,000 bottles

Reason for Recall

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

Distribution

Product Distributed Nationwide in the USA

Type: Voluntary: Firm initiated

Recall Initiated: 2021-05-12

Company

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Global Sanitizers LLC has 6 FDA actions in our database, including 6 recalls.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Global Sanitizers LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Global Sanitizers LLC have FDA actions?

Global Sanitizers LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0780-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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